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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA Announces Bevy of Sterility-Related Recalls

The US Food and Drug Administration's (FDA) MedWatch staff had an unusually busy 6-8 September 2013 weekend, announcing the recall of products from three companies due to serious problems that could potentially affect patient safety.

The Return of Recalls for McNeil

One of the three companies is McNeil Consumer Healthcare, a Johnson &amp; Johnson subsidiary that has conducted a number of high-profile recalls of many widely available products in recent years, including Tylenol and Children's Motrin. Many of those recalls were related to quality deficiencies at the company's Fort Washington, PA facility, which now operates under a consent decree with FDA.

According to regulators, the new problem relates to the company's Concentrated Motrin Infants' Drops. In a recall notice posted on 8 September 2013, FDA said J&amp;J would be recalling three lots, or 200,000 bottles, of the product after discovering "tiny plastic particles approximately 1 mm in size" in a different, undistributed product.

"It was determined that the particles originated in a shipment from a third party supplier of ibuprofen, the active ingredient in [Motrin]," FDA wrote. "Out of an abundance of caution, McNeil is voluntarily recalling the three lots released to the market made with the same batch of active ingredient."

OTC Eye Drops

A second company, Altaire Pharmaceuticals, said it was voluntarily recalling nine lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution due to reports of mold being found in bottles of the product after use.

FDA regulators said in a statement that the problem may have to do with the effectiveness of a preservative used in the product to prevent mold growth.

"A product whose preservative may not be effective could lead to the use of a contaminated product which creates a potential risk for eye infection," FDA wrote in a statement. The products are used to treat mild to moderate dry eye, and are available to consumers on an over-the-counter (OTC) basis at Target, CVS and Walmart stores.

Altaire said there have been no reports of adverse events affecting consumers thus far.

Third Party Testing Woes Continue

The third and final company to announce a recall this weekend is University Compounding Pharmacy (UCP), which follows a growing list of pharmaceutical compounders by recalling lots of select products due to a lack of sterility assurance.

As with at least four other compounding pharmacies in recent weeks, UCP had used the services of a third party laboratory to provide sterility assurance testing. That laboratory, Front Range Labs, was cited by FDA for using improper and unreliable methods for testing products.

Since that inspection, Park Pharmacy &amp; Compounding Center, Wellness Pharmacy Inc, JCB Laboratories and Medaus Pharmacy have all announced recalls due to third-party testing deficiencies, presumably all related to Front Range.

UCP would now mark the fifth such recall. As with the other companies, UCP said it was not aware of any adverse events associated with the recalled products.